Senior Clinical Trial Monitor

Department of Clinical Research
Start date preferentially as soon as possible.

The Faculty of Medicine at the University of Bern is an environment for high-quality, future-oriented research. Strong connections between basic research, engineering sciences, and university hospitals enable a unique setting for translational and patient-centered clinical research. The faculty prioritizes cross-disciplinary research and digitalization, fostering innovation in medical science. It is one of the largest medical faculties in Switzerland and is affiliated with the country's largest hospital complex.

The Department of Clinical Research (DCR) is a joint initiative of the University of Bern's Faculty of Medicine and its university hospitals, including Inselspital and the University Psychiatric Services (UPD). It supports and professionalizes clinical and translational research collaborations.

Our specialized divisions assist researchers throughout the entire research process, from project conception to result dissemination. We provide tailored educational programs and events on all aspects of clinical research, equipping researchers and students with the skills to conduct efficient and impactful studies. Our mission prioritizes patient-centered research, ensuring that patient perspectives are integral to our work.

We are looking for an experienced Clinical Trial Monitor to join our Monitoring team. In this role, you will oversee the integrity and quality of clinical trials, ensuring their safety and adherence to study protocols, ICH-GCP guidelines and regulatory requirements. You will collaborate with investigators, research teams, and sponsors directly contributing to the effectiveness of clinical research.

Duties and responsibilities

• Responsible for the quality control of clinical trials phase I to IV, both nationally and internationally
• Ensure study sites conduct clinical trials in accordance with the protocol, ICH-GCP guidelines, and the applicable regulations
• Perform on site and remote monitoring activities from study initiation to study completion
• Conduct central data monitoring
• Identify, assess, and resolve any site-related issues to ensure smooth trial progress and maintain high data quality
• Document monitoring activities thoroughly, including monitoring reports, protocol deviations, and action items to be addressed
• Collaborate with study teams, investigators, and sponsors to address trial-related concerns and optimize patient safety and trial performance
• Review and evaluate trial data to detect trends, discrepancies, and potential issues
• Perform investigational product (IP) inventory, reconciliation and review storage and security
• Provide training and lectures for various courses related to clinical research

Requirements

• Degree in a scientific field
• Relevant professional experience, ideally with a minimum of 2 years of clinical trial monitoring
• Full professional proficiency in written and spoken German and English, working knowledge of French or Italian
• Excellent understanding of ICH-GCP guidelines, ISO 14155, and applicable regulations
• Strong understanding of diverse medical therapeutic areas, including familiarity with medical terminology
• Experience with R programming preferred
• Excellent verbal and written communication skills
• Strong critical thinking and analytical skills
• Outstanding organizational skills with a proactive, solution-oriented mindset
• Proven ability to deliver high-quality results within established timelines
• Ability to manage multiple projects simultaneously and prioritize effectively
• Willingness and availability to travel, both nationally and internationally
• Confidence and willingness to prepare and deliver presentations

We offer

• An interesting and versatile role in a growing department, contributing to the successful development of the DCR.
• An international and dynamic environment with a motivated and diverse team, dedicated to high quality research.
• A good work-life balance thanks to flexible working hours and the possibility of working from home
• Opportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport'
• Salary and comprehensive social benefits according to cantonal guidelines.